- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168424
Validation of the English Version of the FIMA Questionnaire (FIMAEN)
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Justyna Mazurek, PhD
- Phone Number: 695180984
- Email: justyna.mazurek@umed.wroc.pl
Study Locations
-
-
Florida
-
Winter Haven, Florida, United States, 33880
- Recruiting
- Gessler Clinic
-
Contact:
- Kyle Pochcial, MD
- Phone Number: 863-294-0670
- Email: stoic066@aol.com
-
Principal Investigator:
- Edyta Sutkowska, prof.
-
Sub-Investigator:
- Natalia Kuciel, dr
-
Sub-Investigator:
- Karolina Więckowska, dr
-
Principal Investigator:
- Justyna Mazurek, dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-65+.
Exclusion Criteria:
- younger than 65+
- severe visual impairment
- severe auditory impairment
- poor command of English
- no consent to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Good validity and reliability of the FIMA
Time Frame: 11.2019-12.2020
|
The Questionnaire for Health-Related Resource Use in an Elderly Population is a self-administered questionnaire, which assesses nine features and contains 28 questions altogether: questions 1-18 refer directly to the use of medical and nonmedical services by the elderly, whereas questions 19-28 concern the sociodemographic characteristics of the person surveyed as well as an assessment of questionnaire difficulty and time spent completing it. A total of minimum 60 elderly people, 65 years of age and older, who will be admitted to the Gessler Clinic, USA California, are recruited. All patients will be screening twice for health-related resource use, using the English version of the Questionnaire for Health-Related Resource Use in an Elderly Population. Each patient will be evaluated twice: once within 48 hours at admission and once after two weeks. The English FIMA demonstrate very good test-retest reliability, good validity, and ease of use for elderly people. |
11.2019-12.2020
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mazurek J, Sutkowska E, Szczesniak D, Urbanska KM, Rymaszewska J. FIMA, the questionnaire for health-related resource use in the elderly population: validity, reliability, and usage of the Polish version in clinical practice. Clin Interv Aging. 2018 Apr 27;13:787-795. doi: 10.2147/CIA.S158951. eCollection 2018.
- Seidl H, Hein L, Scholz S, Bowles D, Greiner W, Brettschneider C, Konig HH, Holle R. [Validation of the FIMA Questionnaire for Health-Related Resource Use Against Medical Claims Data: The Role Played by Length of Recall Period]. Gesundheitswesen. 2021 Jan;83(1):66-74. doi: 10.1055/a-1010-6315. Epub 2019 Nov 7. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 103/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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